Sr Regulatory Affairs Specialist

Job Description
Duties & Responsibilities:

• Develop and execute regulatory strategies to support expansion across JPAC markets.


• Lead regulatory readiness for tenders, ensuring alignment with local compliance requirements.


• Support setup of legal entities, distributors, or economic operator structures in new markets.


• Interpret evolving regulatory requirements and translate them into actionable strategies for business teams.


• Collaborate closely with Sales and Commercial teams to support participation in regional tenders.


• Prepare and review regulatory documentation required for tender submissions (e.g., certificates, compliance statements, regulatory approvals).


• Develop regulatory memos, justifications, and gap assessments to demonstrate compliance where formal documentation may not exist.


• Ensure timely delivery of compliant documentation aligned with tender timelines.


• Manage and support submissions to health authorities across JPAC (e.g., CDSCO, PMDA, TGA, HSA, NMPA, etc.).


• Interface with government agencies and notified bodies for approvals and registrations.


• Support company registration and licensing as a distributor, importer, or economic operator in various jurisdictions.


• Maintain regulatory intelligence on regional authority expectations and processes.


• Work cross-functionally with Quality, Clinical, Supply Chain, and Commercial teams to support regulatory and quality initiatives.


• Participate in and lead regulatory workstreams within broader business or transformation projects.


• Ensure alignment between regulatory deliverables and business objectives.


• Track and manage deliverables using project management best practices.


• Support regulatory aspects of product lifecycle management, including renewals, variations, and market expansions.


• Review and assess regulatory impact of product, labeling, or design changes.


• Coordinate submission of regulatory updates and change notifications to applicable markets.


• Ensure global regulatory documentation is adaptable to local requirements.


• Review labeling and promotional claims to ensure compliance with local regulatory requirements.


• Provide regulatory guidance on permissible claims to support commercial strategies.


• Partner with internal stakeholders to update labeling and IFUs as needed.


• Ensure consistency and compliance of regulatory documentation across markets.


• Provide insights to help shape future tender strategies and maintain competitive positioning.


• Support proactive planning by anticipating regulatory trends and risks.


• Utilize regulatory and quality IT systems (e.g., eQMS, RIM systems) to maintain accurate and compliant records.


• Drive process improvements to enhance efficiency of regulatory operations.

Minimum & Preferred Qualifications And Experience

• A minimum of 2 years of work experience in a medical device Class II/ III environment.


• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field


• Advanced degree preferred


• 3-5+ years of regulatory affairs experience within the medical device or healthcare industry


• Strong experience supporting JPAC regulatory environments


• Proven experience with:

+ Regulatory submissions and approvals across multiple APAC countries
+ Government agency interactions and company registration processes

• Experience in setting up distributors, legal entities, or economic operator structures is highly preferred


• Strong understanding of JPAC regulatory frameworks (e.g., CDSCO, PMDA, TGA, HSA, NMPA)


• Expertise in regulatory documentation, submissions, and compliance requirements


• Proficiency in regulatory and quality IT systems (e.g., RIM, eQMS)


• Strong cross-functional collaboration and stakeholder management skills


• Ability to work in fast-paced, ambiguous environments with agility


• Strong analytical and problem-solving skills


• Excellent written and verbal communication skills


• Ability to influence without authority and drive alignment across teams


• High attention to detail and commitment to compliance